510(k) Report

Devices descending from K021318

547 later devices reach Xive Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+6K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K232383iPhysio® SystemEuroteknika20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—